EAC MRH Programme 12 DEC 2019
GOAL To improve access to safe, efficacious and good quality essential medicines for the treatment of diseases of economic importance within EAC region and beyond.
MRH PARTNERS WHO &SWISSMEDIC Technical Assistance (TA) to EAC Secretariat and Partner States NMRAs NEPAD Advocacy and political commitment in enactment of relevant policies and regulatory framework WORLD BANK Financial Management and oversight for the MRH Grant BMGF - Provides Financial Support PARTNER STATES
MRH MRH MA MA • Harmonized technical guidelines developed- 2012- 2014 Harmonization • Approved in Sep, 2019 by EAC process Council of Ministers • 2015 Adoption and domestication by EAC Partner States • 1 st EOI for MA issued in Nov, 2015 - reproductive health products included
Joi Joint t as assessment Process Flow chart including timelines
JA A PROGRESS SS • Total applications: 106 • Total assessed: 101 • Total recommended: 50 • Queried: 53 Recommended • Under evaluation: 7 Queried (Distributed to Assessors) under evaluation Approved • Approved through MAGHP-4 through MAGHP
EAC-SWISSMEDIC COLLABORATION • Revision of existing harmonized guidelines on MER and GMP-2018 • Participation of swissmedic and WHO experts in JA sessions -for clinical and quality review of dossiers • Training of EAC experts on MER and GMP • Training on case/project management
MA MAGH GHP Global- EAC is a member and participates at ICH and ICDRA ( International Conference of Drug EAC Engagement Regulatory Authorities) meetings EAC experts participates in WHO PQ assessment procedure Regional • Developed abridged guidelines to guide on the assessment of products already approved through WHO PQ collaborative procedure to fast tract and reduce registration timeline- within 90 days • Convene joint dossier assessment sessions -13 sessions • Coordinates approval and registration of recommended medical products • Capacity building of PS experts -participate in the WHO PQ program
MA MAGH GHP Global • Participate in WHO PQ process PS Engagement Regional and national • Domestication of harmonized guidelines • Participation in EAC-MRH joint medical product assessment and Good Manufacturing Practice Inspections • Registration of the approved products • Monitoring of Safety and quality of products granted MA • Sharing of skills, experience, knowledge and expertise through twinning programs
• WHO and Swiss medic- CON ONCLUSI SION Technical Expertise • EAC Experts-Technical Access of medicines is a expertise/capacity building collaborative process that require harmonized • PS- Commitment / Financial efforts and technical Support • EAC Sec- Staffing/Commitment, coordination/technical expertise/ capacity building • Partners- financial/ Technical Commitment
One People, One Destiny Asante
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